Child-Resistant Packaging Statements in Drug Product Labeling; Draft Guidance for Industry; Availability

Resumo

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Child- Resistant Packaging Statements in Drug Product Labeling." This guidance is intended to assist applicants, manufacturers, packagers, and distributors who choose to include child-resistant packaging (CRP) statements in prescription and over-the-counter human drug product labeling. The guidance discusses what information should be included to support CRP statements and to help ensure that such labeling is clear, useful, informative, and, to the extent possible, consistent in content and format.